AVAZZIA INC

Address:13140 Coit Rd Ste 515,DALLAS,TX,75240,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Cable, Electrode (IKD) (5) Stimulator, Nerve, Transcutaneous, Over-The-Counter (NUH) (5)

Premarket Exempt

No Yes

Clear

Avazzia - 00851530007546 Catalog Number : AA-LW-2T-250

Device Description : Lead Wire, 2T-250

Device Class : 2

Duns Number: 603638607

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : No

Device Count : 1

Avazzia - 00851530007553 Catalog Number : AA-LW-2T-RB

Device Description : Lead Wire, 2T-RB

Device Class : 2

Duns Number: 603638607

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : No

Device Count : 1

Avazzia - 00851530007560 Catalog Number : AA-LW-4P-RB-B

Device Description : Lead Wire, 4P Banana

Device Class : 2

Duns Number: 603638607

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : No

Device Count : 1

Avazzia - 00851530007577 Catalog Number : AA-LW-4P-RCA

Device Description : Lead Wire, 4P-RCA

Device Class : 2

Duns Number: 603638607

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : No

Device Count : 1

Avazzia - 00851530007584 Catalog Number : AA-LW-250-RCA

Device Description : Lead Wire, 250-RCA

Device Class : 2

Duns Number: 603638607

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : No

Device Count : 1

Avazzia - 00851530007591 Catalog Number : A4-AB

Device Description : Avazzia Blue OTC device.

Device Class : 2

Duns Number: 603638607

Premarket Exempt : No

Product Code : NUH

Prescription Use : No

Device Count : 1

Avazzia - 00851530007607 Catalog Number : A4-AB-K

Device Description : Convenience kit with Avazzia Blue OTC device, conductive pads, lead wire, and zipper pouch

Device Class : 2

Duns Number: 603638607

Premarket Exempt : No

Product Code : NUH

Prescription Use : No

Device Count : 1

Avazzia - 00851530007614 Catalog Number : A4-AB-K-Y

Device Description : Convenience kit with Avazzia Blue OTC device, conductive pads, Y electrode, lead Convenience kit with Avazzia Blue OTC device, conductive pads, Y electrode, lead wires, and carry case.

Device Class : 2

Duns Number: 603638607

Premarket Exempt : No

Product Code : NUH

Prescription Use : No

Device Count : 1

Avazzia - 00851530007683 Catalog Number : A4-MS-OTC

Device Description : Med Sport OTC device.

Device Class : 2

Duns Number: 603638607

Premarket Exempt : No

Product Code : NUH

Prescription Use : No

Device Count : 1

Avazzia - 00851530007690 Catalog Number : A4-MS-K-OTC

Device Description : Convenience kit with Med Sport OTC device, conductive pads, lead wire, and zipper pouch

Device Class : 2

Duns Number: 603638607

Premarket Exempt : No

Product Code : NUH

Prescription Use : No

Device Count : 1

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